Associate Director Clinical Operations

Phathom Pharmaceuticals•Buffalo Grove, IL

1d•Hybrid

About The Position

Phathom is seeking an experienced and strategic Associate Director, Clinical Operations to lead the execution of global clinical development programs and advance innovative therapies. The role is responsible for planning, overseeing, and delivering complex clinical studies and programs in accordance with regulatory requirements, quality standards, timelines, and budgets. The position works with CROs, vendors, and cross-functional stakeholders in a fast-paced biotechnology environment.

Requirements

Bachelor's degree; preferably in a scientific discipline.
Minimum of 8 years of clinical/operations experience within the pharmaceutical, biotechnology, or CRO industry.
Experience managing complex, global clinical trials across multiple therapeutic areas.
Demonstrated success overseeing CROs, vendors, investigators, and external partners.
Strong understanding of ICH-GCP, FDA regulations and US CFR requirements, EU Clinical Trial regulations, and global clinical research compliance standards.
Experience with regulatory inspections and audit readiness activities.
Excellent project management, organizational, and prioritization skills.
Strong written, verbal, and presentation communication abilities.
Proven ability to influence stakeholders and lead cross-functional teams in a matrix environment.

Responsibilities

Lead and oversee execution of multiple clinical studies within assigned development programs.
Drive operational strategy and execution in support of clinical development plans and program objectives.
Manage complex studies that may involve multiple indications, interim analyses, DSMBs, endpoint review committees, and global vendors.
Ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, regulatory requirements, and company procedures.
Oversee project scope, critical path activities, timelines, milestones, and risk mitigation plans.
Select, manage, and oversee CROs and external vendors to ensure quality performance and delivery of contracted services.
Lead vendor budget discussions, contract negotiations, and performance management; escalate and resolve operational or vendor performance issues.
Partner with CROs to develop study management, enrollment, communication, monitoring, and risk management plans.
Develop and manage program budgets and forecasts, partnering with Finance on forecasting, enrollment projections, and spend management.
Provide senior leadership with updates on program status, risks, timelines, and financial performance.
Support operational due diligence for new compounds, partnerships, and business development opportunities.
Represent Development Operations for assigned programs and collaborate with Clinical Development, Regulatory Affairs, Medical Writing, Biostatistics, Data Management, and other stakeholders.
Participate in audit and inspection readiness activities and support regulatory interactions.
Contribute to departmental process improvements, strategic initiatives, and operational excellence.
Provide operational expertise in developing and reviewing protocols, Clinical Study Reports, Investigator Brochures, INDs, IMPDs, NDA and MAA submissions, and enrollment and risk management plans.
Support preparation for regulatory agency meetings and health authority interactions.
Guide, mentor, and support Clinical Operations team members and cross-functional colleagues.
Contribute to department training, development initiatives, and resource planning.

Benefits

Competitive medical, dental, and vision coverage options with low monthly premiums.
Roth and Traditional 401(k) savings plan with annual employer match.
Long-term incentive equity compensation program.
Employee Stock Purchase Plan (ESPP).
Comprehensive paid leave programs, including 16 weeks of paid parental leave for all new parents.
Four-week part-time Bridge-Back-to-Work Program.
Hybrid and flexible working arrangements.
Unlimited time off.
17 paid company holidays in addition to a year-end winter shutdown period.
Annual fitness and wellbeing reimbursement.
Company-provided life and Accidental Death & Dismemberment (AD&D) insurance.
Company-provided short- and long-term disability benefits.
Company-funded HSA plan.
Accident and Hospital Indemnity insurance.
Employee Assistance Program (EAP).
Employee recognition program.